Transcript PRESCRIPTION DRUG STRATEGIES FOR STATES

Using Evidence to Make Prescription
Drug Purchasing Decisions
JOHN SANTA MD MPH
Grant Administrator
Attorney Generals Consumer and Prescriber Grants Program
Center for Evidence-based Policy
Oregon Health & Science University
“More than any other time in history,
mankind faces a crossroads. One path
leads to despair and utter hopelessness.
The other to total extinction. Let us pray we
have the wisdom to choose correctly.”
Woody Allen
Wisdom to Choose
• There are more than these two options
• Act like a purchaser. Understand:
• playing field/negotiating table
• who you represent
• who the “sellers” are.
• DON’T BLINK
Playing Field
American Culture
• Tension between individual freedom and
equality
• Individual freedom
• Religion
• Capitalism
• Equality of opportunity
• Land of opportunity, not economic security
Playing Field
Employer based, FFS
• Unlimited access to the most
sophisticated acute care in the world
when desperately ill.
• Multiple tiers of care unless need acute
care, desperately ill.
• Unlimited access to the most health care
information in the world in every
imaginable medium.
Playing Field
“Perfect Competition”
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Homogeneity of product
Perfect information
Freedom of entry and exit
Numerous small firms and customers
Microeconomics Principles and Policy, Baumol, W.J., and Binder A.S.
Who you represent
Systems are perfectly designed to get
the results they achieve.
Who you represent
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Working people
Sick people—high % chronic diseases
People 50-65 years old
You are negotiating a substantial % of
their income. Annual income of families at
100% of federal poverty level
Who you represent
• Almost 2 million adults (almost 1%) file for
bankruptcy every year
• 28% major factor = illness/injury
• 27% leading factor = uncovered medical bills
• 21% cite loss of income due to illness
• 75% had health insurance
• Average age in forties, over 90% middle class
• HEALTH CARE COSTS NOW THE MAJOR
CAUSE OF BANKRUPTCY
Archives of General Psychiatry
June 2006
• In 2002, antipsychotic drugs were prescribed to 1,438 children per
100,000, up from 275 children per 100,000 between 1993 and 1995
– five fold increase;
• One-third of children who received antipsychotic drugs had
behavior disorders, one-third had psychotic symptoms or
developmental problems and one-third had mood disorders;
• Overall, more than 40% of children who received an antipsychotic
drug were taking at least one other antipsychotic medication;
• Between 2000 and 2002, more than 90% of prescriptions analyzed
were for newer atypical antipsychotic drugs which were introduced
in the early and mid-1990s;
• Caucasian boys are the most common recipients of antipsychotic
medications.
New York Times, June 2006
"We are using these medications and don't
know how they work, if they work or at
what cost," John March, a professor of
child and adolescent psychiatry at Duke
University, said. He added, "It amounts to
a huge experiment with the lives of
American kids, and what it tells us is that
we've got to do something other than
[what] we're doing now."
Sellers
Transparency/Conflict of Interest
• 16 Billion on RX marketing---much more
than spent on medical education or
research
• Academic medical centers especially
conflicted
• Gifts/relationships make a difference
Sellers
Conflict of Interest
“The medical profession has sold its soul in
exchange for what can only be described
as bribes from manufacturers of drugs
and medical devices”
NY Times Jan 2006
Is there hope?
“We can’t solve problems by using the same kind
of thinking we used when we created them.”
Albert Einstein
VA
• Government administered and provided
health care system
• Means tested
• Provides a basic benefit for a fixed
amount
• Integrated system
Who are VA Patients?
Disadvantaged Populations
• Older
~49% over age 65
• Sicker
~Compared to Age-Matched Americans
-3 additional Medical Diagnoses
-1 Additional Mental Health Diagnosis
• Poorer
~70% with annual incomes < $26,000
~40% with annual incomes < $16,000
• Homelessness
~1/3 of all homeless individuals are veterans approximately 200,000
More than 400,000 may experience homelessness in a given year
• Changing Demographics
~4.5% female overall
Improved Efficiency:
Enrollees, Patients & Resources/Patient
1996-2004
$12.0
7
Enrollees
$10.0
6
$8.0
5
4
Resources/Patient in Nominal Dollars
$6.0
3
$4.0
Veteran Patients
2
$2.0
1
0
$0.0
1996
1997
1998
1999
2000
Fiscal Year
2001
2002
2003
2004
Resources Per Patient (in Thousands)
Enrollees and Patients (in Millions)
8
Economies of Scale: VA’s PBM
(Pharmacy Benefits Management Program) 1996 - 2004
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$4.72 Billion in savings:
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In drug acquisition costs from standardization contracting ($1.92B)
In labor/mail costs through CMOP prescription processing (>$2.3B)
In negative distribution fees (rebates) the Pharmaceutical Prime Vendor
contract (~$503M)*
• * Savings achieved in collaboration with VA’s National Acquisition Center
• Quality Improvements resulting in unmeasured cost savings:
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CMOP error rate reduction (approaching six sigma)
Two-thirds reduction in reported medication errors through BCMA
Evidence-based prescribing guidance
Outcomes assessment to monitor/maintain safe prescribing
Portland VA
Medical
Center 2005
HEDIS
Commercial
2004
HEDIS
Medicare 2004
HEDIS
Medicaid 2004
Breast cancer screening
72%
73%
74%
54%
Cervical cancer screening
89%
81%
Not Reported
65%
Colorectal cancer screening
71%
49%
53%
Not Reported
LDL Cholesterol < 100 after AMI,
59%
51%
54%
29%
Diabetes: Poor control HbA1c > 9.0%
PTCA, CABG
(lower is better)
15%
31%
23%
49%
Diabetes: Cholesterol (LDL-C)
controlled (<100)
61%
40%
48%
31%
Diabetes: Cholesterol (LDL-C)
controlled (<130)
76%
65%
70%
41%
Diabetes: Eye Exam
79%
51%
67%
45%
Hypertension: BP <= 140/90 most
recent visit
70%
67%
65%
61%
Follow-up after Hospitalization for
Mental Illness (30 days)
77%
76%
61%
55%
Immunizations: influenza, (note
patients age groups)
73%
38.9%
(50-64)
74.8%
(65 and older)
70%
(65 and older)
Immunizations: Pneumococcal,
patients 65 and older
98%
Not Reported
Not Reported
65%
CLINICAL PERFORMANCE
INDICATOR
Balancing Access & Resources
Waiting for Medically Non-Urgent Care
Numbers waiting over 30 days for elective care by region.
VA Patient Satisfaction:
• VA Inpatient – 83%
• Private Sector Inpatient -*73%
• VA Outpatient – 80%
• Private Sector Outpatient - *75
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*American Customer Satisfaction Index
Are there problems?
• FDA---recent IOM report---”sweeping”
changes needed
• CMS---prohibited from using evidence
funded by the Medicare Modernization Act
that compares drugs
• Academic centers/pharma companies--growing concerns about corruption--www.hcrenewal.blogspot.com
“We are drowning in information but
starved for knowledge.”
John Naisbitt
Megatrends, 1982
Do you believe that the health care services
you receive should be based on the best
and most recent research available?
Yes
No
Don’t know
95%
4%
1%
Source: National survey, 2005, Charlton Research
Company for Research!America
The Ethics of Pharmaceutical Benefit
Management
Burton S.L. et al, Health Affairs, 20, #5, Sept/Oct 2001
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Accept resource constraints
Help the sick
Protect the worst off
Respect autonomy
Sustain trust
Promote inclusive decision making
Major issues
• Effectiveness---especially comparative
effectiveness. How does Drug A compare
to Drug B??
• Safety---especially longer term safety
• Off label uses---uses not approved of by
the FDA
Lets just focus on comparative effectiveness
$$ Market Share Over 24 Months — Single Rx Class
$500,000
$450,000
$400,000
$350,000
$$/Month
$300,000
$250,000
$200,000
$150,000
$100,000
$50,000
$0
Months – 1/00 to 6/02
The Prescription Drug Purchasing
Process
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Information
Price
Credibility/Transparency/Trust
Implementation
Evaluation
The Drug Effectiveness Review Project
• Systematic drug class reviews focusing on
comparative effectiveness and safety
• Focus on the most important 25 drug classes
• Update every 12-24 months (sooner if needed)
• Each participant uses local decision makers to
draw conclusions from the evidence for their
use
Drug Classes
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13.
Proton Pump Inhibitors
Long-acting Opioids
Statins
Non-steroidal Anti-Inflammatory
Drugs
Estrogens
Triptans
Skeletal Muscle Relaxants
Oral Hypoglycemics
Over Active Bladder, Drugs to
treat
ACE Inhibitors
Beta Blockers
Calcium Channel Blockers
Angiotensin II Receptor
Antagonists
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25.
26.
2nd Generation
Antidepressants
Antiepileptic Drugs in Bipolar
Mood Disorder and
Neuropathic Pain
2nd Generation Antihistamines
Atypical Antipsychotics
Inhaled Corticosteroids
ADHD and ADD, Drugs to treat
Alzheimers, Drugs to treat
Anti-platelet Drugs
Thiazolidinedione
Newer Antemetics
Sedative Hypnotics
Targeted Immune Modulators
Inhaled Beta Agonists
Overview of Project
PRIVATE NON PROFITS AND STATES
CENTER FOR EVIDENCE-BASED POLICY
COORDINATING EVIDENCE BASED PRACTICE CENTER
OHSU EPC
UNC EPC
CALIF RAND EPC
Governance Group
• 17 Organizations
• State Medicaid organizations
• State employee plans
• Private organizations
• Decisions to be made
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Key policy decisions
Drug classes to be reviewed
Key questions
Timelines
Currently Announced
Participating Organizations
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Alaska
Arkansas
California
Oregon
Washington
Idaho
Wyoming
Kansas
New York
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Michigan
Missouri
Minnesota
North Carolina
Wisconsin
CHCF
CCOHTA
Montana
Center for Evidence-based Policy
• MISSION: To address policy challenges by
applying the best available evidence through
self-governing communities of interest.
• Department of Public Health and Preventive
Medicine, Oregon Health & Science University
• Supports collaboration, facilitates
communication
OHSU Evidence-based Practice Center
• Designated an EPC by AHRQ
• Department of Medical Informatics and
Clinical Epidemiology, OHSU
• Agreement with Center for drug class
reviews.
• Credible, experienced (10 years) source
of comprehensive information.
Evidence-based Practice Center
• Emphasize getting questions right
• State of art methods for conducting
systematic reviews
• Multiple reviewers
• Accustomed to timelines, deliverables
• Extensive, external peer review
• Many EPC products available for the
world to evaluate
Expert Strategy
• Experts may underplay controversy or select
only supportive evidence
• Without systematic approach bias may be
introduced
• Experts may ask good research questions but
the wrong questions for patients and providers
• Experts may not be aware of all evidence
• Experts may or may not disclose conflicts
Systematic Review Process
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Problem formulation/key questions
Find evidence
Select evidence
Synthesize and present
Peer review and revision
Maintain and update
Key Questions
• EPC drafts initial KQ using standard
comparative review approach
• Three questions
• Comparative effectiveness
• Comparative safety profile
• Subpopulations
• Multiple discussions
• Multiple inputs
• Consensus process
Key Questions
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Drugs to be included in class
Indications
Outcomes of interest
Types of studies
Possible Results
• No good quality comparative studies
done.
• Good studies done. No differences.
• Good studies done. Small differences.
• Good studies done. Significant
differences.
Some examples
• COX 2s/NSAIDs—never more effective,
risks were suppressed
• Heartburn medicines---No differences in
effectiveness for vast majority of patients
• Long acting narcotics---little comparative
evidence
• Antidepressants---all effective at similar
levels, different side effect profiles
Subpopulations
• All reports include evidence focused on
subpopulations
• Gender, race, ethnicity, age, income
• Evidence frequently not found
• General population evidence vs no evidence
• Strive for studies that meet rigorous standards
for all populations.
• If we don’t make decisions based on evidence
can we ever hope to get it?
Update Reports
• Every 12-24 months — some continuously
updated every 7 months
• Start with key questions from previous
final report
• Integrate input from local discussions
• New drugs, new studies, additional issues
added
• Chance to improve reports
Final Comments
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Credible, transparent, explicit, trustworthy
Good information, reasonably current
Consumers/patients have access to info
Insist practitioners disclose financial
relationships to purchasers and patients
• Don’t blink
• Shift market share
More Information
• Project website at
www.ohsu.edu/drugeffectiveness.
• Email comments/questions regarding the Center
to [email protected].
• Call John Santa at 503-494-2691 if questions
regarding the Center or Project.